The secondary endpoints of the trial were the number of ...
Supplementary material 2: secondary endpoints
The secondary endpoints of the trial were the number of severe systemic and benign flares, the number of patients withdrawing GC and achieving renal remission. A severe systemic flare was defined as any of the following events: CNS disease (psychosis, grand mal seizures, transverse myelitis, in the absence of offending drugs or metabolic derangements), thrombocytopenia (< 100,000/ml) of recent onset, haemolytic anaemia (decrease of ≥ 3 g/dl in the blood hemoglobin level, coincident with a rise in conjugated bilirubin level of ≥ 0.6 mg/dl and a reticulocyte count > 5 %), lupus pneumonitis (fever, cough, pulmonary infiltrates on x-ray in the absence of infection), lupus myocarditis (congestive heart failure in the absence of coronary artery disease or other non-lupus related causes), extensive skin vasculitis or serositis (not due to lung or pleural infection and not responding to low-dose glucocorticoids and/or NSAIDs). A benign flare, such as arthritis, skin rash, was defined as a lupus flare not meeting the definition of a renal flare or a severe systemic flare. Renal remission was defined as a serum creatinine ≤ 1.4 mg/dl and a 24-h proteinuria < 1g and a urinary RBC count < 10/high power field, according to clinical practice in 2001, when this trial was designed. Of note, renal remission was not a prerequisite to receive maintenance treatment with AZA or MMF and could therefore be reached at any time during follow-up.
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